Chemically, isotretinoin is 13-cis-retinoic acid and is related to both
retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline
powder with a molecular weight of 300.44. The structural formula is:

What are the possible side effects of isotretinoin (Accutane, Amnesteem, Claravis, Sotret)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using isotretinoin and call your doctor at once if you have any of these serious side effects:

What are the precautions when taking isotretinoin (Accutane)?

Before taking isotretinoin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as soybean, parabens), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. Talk to your pharmacist for more details.

Accutane Consumer (continued)

SIDE EFFECTS: Dry lips and mouth, minor swelling of the eyelids or lips, crusty skin, nosebleeds, upset stomach, or thinning of hair may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Isotretinoin may infrequently cause disease of the pancreas (pancreatitis) that may rarely be fatal. Stop taking this medication and tell your doctor immediately if you develop: severe stomach pain, severe or persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking isotretinoin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as soybean, parabens), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. Talk to your pharmacist for more details.

Do not donate blood while you are taking isotretinoin and for at least 1 month after you stop taking it.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Isotretinoin can affect your night vision. Do not drive, use machinery, or do any activity that requires clear vision after dark until you are sure you can perform such activities safely.

If you wear contact lenses, you may not tolerate them as well as usual while using this medication. Contact your doctor for more information.

Do not have cosmetic procedures to smooth your skin (e.g., waxing, laser, dermabrasion) during and for 6 months after isotretinoin therapy. Skin scarring may occur.

Avoid the use of alcohol while taking this medication because it may increase the risk of certain side effects (e.g., pancreatitis).

Limited information suggests isotretinoin may cause some bone loss effects. Therefore, playing contact or repetitive impact sports (e.g., football, basketball, soccer, tennis) may result in bone problems, including an increased risk of broken bones. Limited information also suggests isotretinoin may stop normal growth in some children (epiphyseal plate closure). Consult your doctor for more details.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially the effects on bones.

Caution is advised when using this drug in children because they may be more sensitive to its effects, especially back/joint/muscle pain.

This drug must not be used during pregnancy or by those who may become pregnant during treatment. If you become pregnant or think you may be pregnant, inform your doctor immediately. See also Warning section.

You must have two negative pregnancy tests before starting this medication. You must have a monthly pregnancy test during treatment with isotretinoin. If the test is positive, you must stop taking this medication and consult your doctor immediately.

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Accutane Patient Information Including Side Effects

Brand Names: Accutane, Amnesteem, Claravis, Sotret

Generic Name: isotretinoin (oral) (Pronunciation: EYE so TRET i noyn)

What is isotretinoin (Accutane)?

What are the possible side effects of isotretinoin (Accutane)?

What is the most important information I should know about isotretinoin (Accutane)?

What should I discuss with my healthcare provider before taking isotretinoin (Accutane)?

How should I take isotretinoin (Accutane)?

What happens if I miss a dose (Accutane)?

What happens if I overdose (Accutane)?

What should I avoid while taking isotretinoin (Accutane)?

What other drugs will affect isotretinoin (Accutane)?

Where can I get more information?

What is isotretinoin (Accutane)?

Isotretinoin is a form of vitamin A. It reduces the amount of oil released by oil glands in your skin, and helps your skin renew itself more quickly.

Isotretinoin is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.

Isotretinoin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of isotretinoin (Accutane)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using isotretinoin and call your doctor at once if you have any of these serious side effects: